Japan's Pharmaceuticals and Medical Devices Agency (PMDA)

The PMDA was established in 2004 as a consolidation of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and part of the Japan Association for the Advancement of Medical Equipment (JAAME). The PMDA is an independent administrative agency that works with the MHLW to ensure the safety and quality of drugs and medical devices in Japan.

The PMDA has three primary functions: drug and medical device reviews, post-marketing safety, and relief services for adverse health effects. The PMDA conducts scientific reviews of all new pharmaceutical and device applications and provides consultative services for clinical development. In order to ensure compliance, the PMDA conducts inspections and audits for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP).

For drugs and devices already on the market, the PMDA collects and disseminates information about their safety and quality and provides consultative services for consumers. For people who have suffered adverse health effects from a drug or medical device, the PMDA offers medical expenses, disability pensions, and bereaved family pensions.

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